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2015年11月6日,国家食品药品监督管理总局公布了《药品上市许可持有人制度试点方案(征求意见稿)》,向社会公开征求意见。所谓的药品上市许可持有人(以下简称MAH)制度,是指将上市许可与生产许可分离的管理模式。在MAH制度下,上市许可和生产许可相互独立,MAH可以将产品委托给生产企业生产,但药品的安全性、有效性和质量可控性均由MAH对公众负责。在
On November 6, 2015, the State Food and Drug Administration announced the Pilot Scheme on Pharmaceutical Listing Licensee System (Draft for Comment) to solicit opinions from the public. The so-called Pharmaceutical Listing Permit Holder (hereinafter referred to as the MAH) system refers to a management model that separates the listing license from the production license. Under the MAH system, the permit of listing and the permit of production are independent of each other. MAH can entrust the product to the manufacturing enterprise. However, the safety, effectiveness and quality control of the drug are the responsibility of the public. in